Device product
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Z-1707-2024
Product summary
- Event
- Event 94401
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4080 units
- Official record key
device-enforcement:Z-1707-2024
Official wording
Reason: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information: UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441; (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0, Z06CBH
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration